NL-OMON52634招募中2 期
eo-adjuvant FOLFOXIRI and chemoradiotherapy for high risk (*ugly*) locally advanced rectal cancer. - MEND-IT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •18 years or older
- •WHO performance score 0-1.
- •Fit for (modified dose) triple chemotherapy (FOLFOXIRI)
- •Histopathologically confirmed rectal cancer.
- •Lower border of the tumour located on or below the sigmoidal take-off as
- •established on MRI of the pelvis.
- •Confirmed high-risk locally advanced rectal cancer, at high risk of treatment
- •failure, meeting one of the following imaging based criteria:
- •o Tumour invasion of mesorectal fascia (MRF+)
- •o The presence of grade 4 extramural venous invasion (mrEMVI)
- •o The presence of tumour deposits (TD)
- •o The presence of bilateral extramesorectal lymph nodes with a short-axis size
- •>= 7mm (LLN) or extensive LLN involving pelvic side wall structures, at high
- •risk of an incomplete resection.
- •Resectable disease as determined on magnetic resonance imaging (MRI) or
- •deemed resectable disease after neoadjuvant treatment.
- •Expected gross incomplete resection with overt tumour remaining in the patient
- •after resection, tumour invasion in the neuroforamina, encasement of the
- •ischiadic nerve and invasion of the cortex from S2 and upwards are considered
- •not resectable
- •Written informed consent.
排除标准
- •Evidence of metastatic disease at time of inclusion or within six months
- •prior to inclusion except for patients with enlarged iliac or inguinal lymph
- •nodes and aspecific lung noduli.
- •Homozygous DPD deficiency.
- •Any chemotherapy within the past 6 months.
- •Any contraindication for the planned systemic therapy (e.g. severe allergy,
- •pregnancy, kidney dysfunction and thrombocytopenia), as determined by the
- •medical oncologist.
- •Previous radiotherapy in the pelvic area precluding chemoradiotherapy with a
- •dose of 50 - 50.4 Gy.
- •Any contraindication for the planned chemoradiotherapy (e.g. severe allergy
- •to the chemotherapy agent or no possibility to receive radiotherapy), as
- •determined by the medical oncologist and/or radiation oncologist.
- •Any contraindication to undergo surgery, as determined by the surgeon and/or
- •anaesthesiologist.
- •Concurrent malignancies that interfere with the planned study treatment or
- •the prognosis of the resected tumour.
研究者
相似试验
招募中
2 期
Induction chemotherapy for locally advanced rectal cancer.2023-509758-74-00Catharina Ziekenhuis Stichting128
招募中
1 期
Induction chemotherapy for locally advanced rectal cancer.ocally advanced rectal cancerMedDRA version: 20.0Level: PTClassification code: 10038038Term: Rectal cancer Class: 100000004864CTIS2023-509758-74-00Catharina Ziekenhuis Stichting128
招募中
不适用
eo-adjuvant FOLFOXIRI and chemoradiotherapy for high risk (ugly”) locally advanced rectal cancer.NL-OMON28766Catharina Hospital Eindhoven128
撤回
2 期
FOLFOXIRI Chemotherapy Alone as Neoadjuvant Treatment for Circumferential Radial Margin (CRM) Positive Rectal CancerRectal CancerNCT03161574Guangxi Medical University
Unknown
2 期
Totally Neoadjuvant FOLFOXIRI + Short-course Radiation + XELOX in Patients With Locally Advanced Rectal CancerRectal NeoplasmsDrug TherapyRadiationNCT03484221China Medical University, China30